Metabolomic Profiling of Novel Mediators of Vascular Function

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Metabolomic Profiling of Novel Mediators of Vascular Function

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00762242
• Other study ID #: 2007P-000669
• Status: Terminated
• Phase: N/A
• First received: September 26, 2008
• Last updated: December 8, 2016
• Start date: May 2007
• Est. completion date: February 2018

Study information

• Verified date: December 2016
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to identify and characterize specific chemicals and metabolic pathways that change with forearm ischemia. These changes will be compared with forearm blood flow and flow-mediated vasodilation of the brachial artery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults age 18 or older

• Type 2 diabetes mellitus

Exclusion Criteria:

• Type 1 diabetes mellitus

• Type 2 diabetics taking insulin, thiazolidinediones (rosiglitazone or pioglitazone), an amylin analog (Symlin [pramlintide]), or incretin mimetics (Byetta [exenatide])

• Pregnancy

• Uncontrolled hypertension, > 180/100 mmHg

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Procedure:
• blood sampling and brachial artery ultrasound
Intravenous blood sampling will be performed before and 15 seconds, 30 seconds, 1,2,5,10,and 30 minutes following an ischemic stimulus (inflation of a blood pressure cuff to suprasystolic pressure for 5 minutes) Brachial artery ultrasound imaging will be performed before and 1 minute after a 5 minute ischemic stimulus, to assess endothelium-dependent vasodilation of the brachial artery. Following completion of blood sampling, an additional "resting" image of the brachial artery will be obtained. Sub-lingual nitroglycerin will be administered, and the artery will be imaged again after 3 minutes, to assess endothelium-independent vasodilation.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline (pre-forearm ischemia) in circulating metabolites compared with post-ischemic forearm measurements		pre/post 5 minute ischemic stimulus